November 14, 2006 -- 一篇对肾动脉狭窄病患以侵入性医疗或支架植入之血管成形术治疗的文献系统分析报告指出，两种治疗方式得到相似的肾功能结果，但是对那些有两种疾病的病患来说，血管成形术之后的血压控制比较好，不过这个证据尚嫌薄弱。
本研究结果发表于10月24日的内科医学年鉴(Annals of Internal Medicine)期刊线上版。
Tufts新英格兰医学中心的主要研究者Ethan Balk医师向Medscape表示，我们的主要发现并不令人意外，他解释，该团队发现并未直接比较药物治疗和支架血管成形术治疗肾动脉狭窄的文献，没有足够的证据支持其中一种治疗方式优于另外一种。
【寻找3个问题的答案】
作者解释，肾动脉粥状硬化狭窄在老年人病例渐增，其中30%可能还有冠状动脉疾病；他们指出，治疗选择包括侵入式医疗或者以支架植入之经皮血管腔内成形术；即使没有足够的证据支持，从1996年到2000年，后者的医疗照护需求超过两倍。
为了确定哪种病患可由支架血管成形术获得最佳治疗利益，国家健康研究中心赞助一项大型的“肾动脉粥状硬化之心血管影响(Cardiovascular Outcomes in Renal Atherosclerotic Lesions/ CORAL)”研究，本研究预计在2010年发表研究结果，同时，本篇回顾系受健康照护研究与品质
管理局委托。
其目标在回答以下3个问题：
* 肾动脉粥状硬化狭窄成年病患用药物治疗比血管再形成术更有效或更没效的证据是什么，这些治疗的副作用是什么？
* 病况改善或恶化的特征和诊断技巧是什么？
* 病况改善或恶化的治疗变项是什么？
该研究团队对MEDLINE资料库内至2005年9月为止的所有有关肾动脉粥状硬化狭窄成年病患死亡率、肾功能、血压、心血管病变或副作用的报告加以回顾分析，共有9篇直接比较，8篇自然史、25篇血管成形术、4篇
手术，和4篇药物治疗研究符合本研究的分析规范；证据等级分成完整的、可接受的、以及薄弱的。
【缺乏完整证据】
直接比较侵入式医疗和支架植入血管成形术的研究中没有发现完整的证据，9篇直接比较的报告中，2篇是随机的控制试验，比较无支架的血管成形术和药物治疗，其他是比较各种血管再形成术与各种药物治疗，这些研究的证据被视为可接受的，有两种治疗在肾功能方面显示没有显著改变；一篇有，不过其中有两种疾病的病患，在血管成形术之后的血压比药物治疗者显著降低达26/10 mm Hg；小型研究的薄弱证据显示，两种治疗方式的死亡率和心血管事件相似。
作者对整体的结论认为，没有足够证据可以清楚地支持其中一种治疗方式优于另外一种，在副作用方面，诊断
检验或其他不同治疗变项上，也缺乏好的证据。
他们结论指出，使用血管成形术可以改善肾脏的血流是其吸引力所在，肾动脉粥状硬化狭窄的治疗应该被更完整的考虑，他们认为需要更进一步的评估，以确定哪种方式是洽当的；进行中的CORAL 试验，纳入的病患是严重肾动脉粥状硬化狭窄(至少有60% 狭窄)和收缩型
高血压，该试验预期可对如何为这些病患选择最好的治疗策略上带来一丝曙光。
Ann Intern Med.。线上发表于 October 24, 2006。
Is Revascularization or Medical Therapy Best for Renal Artery Stenosis?
By Marlene Busko
Medscape Medical News
November 14, 2006 — A systematic review of studies of aggressive medical therapy vs angioplasty with stent placement for renal artery stenosis suggests similar kidney function outcomes but possibly better blood pressure control after angioplasty, particularly in patients with bilateral disease. The evidence, however, is sparse and less than optimal.
The results are published online October 24 in the Annals of Internal Medicine.
"Our major findings were not surprising," lead study author Ethan Balk, MD, at Tufts–New England Medical Center, in Boston, Massachusetts, told Medscape. He explained that the team found that studies directly comparing medical therapy with angioplasty with stents for renal artery stenosis are lacking, and there is no robust evidence that clearly supports one treatment over the other.
Seeking Answers to 3 Questions
The authors explain that atherosclerotic renal artery stenosis is increasingly common in the aging population and might be found in 30% of patients with coronary artery disease. They add that treatment options include aggressive medical therapy or percutaneous transluminal angioplasty with stent placement. The number of Medicare claims for the latter more than doubled from 1996 to 2000, despite uncertain evidence supporting this treatment.
To determine which patients would most benefit from angioplasty with stents, the National Institutes of Health sponsored the large Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL) study, which is expected to report results in 2010. In the meantime, this review was commissioned by the Agency for Healthcare Research and Quality.
It aimed to answer 3 key questions:
What is the evidence that medical therapy is more or less effective than revascularization for adults with atherosclerotic renal artery stenosis, and what adverse events have been associated with these treatments?
What baseline characteristics and diagnostic tests are associated with improved or worse outcomes?
What treatment variables are associated with improved or worse outcomes?
The team searched the MEDLINE database from inception to September 2005 for studies involving adults with atherosclerotic artery stenosis that reported mortality, kidney function, blood pressure, cardiovascular events, or adverse events. A total of 9 direct-comparison, 8 natural-history, 25 angioplasty, 4 surgery, and 4 medical-treatment studies met their criteria. Evidence was graded as robust, acceptable, or weak.
Lack of Robust Evidence
No trial reported robust evidence obtained from a direct comparison of aggressive medical therapy vs angioplasty with stent placement. Of the 9 direct-comparison studies, 2 were randomized, controlled trials of angioplasty without stents vs medical therapy, and the others compared multiple revascularization strategies with various medical treatments. Evidence from these studies, which was deemed to be acceptable, showed no significant differences in kidney function outcomes for the 2 treatments; 1 study did show, however, that patients with bilateral disease experienced a significant net decrease in BP of 26/10 mm Hg after angioplasty compared with medical therapy. Weak evidence from small studies showed that mortality rates and cardiovascular outcomes were similar with the 2 treatments.
The authors summarize that, overall, there was insufficient evidence to clearly support one current treatment strategy over the other. They also found a lack of good evidence about adverse events, diagnostic tests, or the impact of different treatment variables.
"Although the use of angioplasty to improve blood flow to the kidneys holds appeal, the treatment of atherosclerotic renal artery stenosis is probably considerably more complicated," they conclude. They add that further evaluation is needed to determine which intervention is optimal. The ongoing CORAL trial, which is enrolling patients with severe atherosclerotic renal artery stenosis (at least 60% narrowing) and systolic hypertension, should shed further light on selecting the best management strategies for these patients.
Ann Intern Med. Published online October 24, 2006.
作者：
Marlene Busko 2007-6-20